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Fdanewsdevicedailybulletin

Feb. 24, 2012

Vol. 9 No. 39

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Panel Nixes CES Reclassification; Benefits Don’t Trump Lack of Data

Despite few safety risks, a sharply divided FDA advisory panel voted not to reclassify cranial electrotherapy stimulation (CES) devices from Class III to Class II because of a lack of data to support the products’ efficacy. Read More

Supplier Quality Management Key to Curbing Product Liability Risk: Expert

Getting supplier quality under control is crucial if devicemakers wish to avoid the risk of product liability and its accompanying financial hit, industry experts say. Read More

Faulty Software Prompts Alert for Therapy Device

Baxter Healthcare is issuing an alert about three problems with its Aquarius hemofiltration machine using software version 6.01. Read More

DOJ Official: ‘Everyone Is Doing It’ No Excuse for Off-Label Promotion

Last year, the federal government collected $1.45 billion in settlement from pharmaceutical and medical device companies, and the most common charge of alleged misconduct was off-label promotion, according to law firm Skadden. Read More

CardioFocus Launches Pivotal Trial for HeartLight Ablation System

CardioFocus successfully treated the first patient in a pivotal trial of its HeartLight endoscopic ablation system for atrial fibrillation. Read More

J&J Backs Down to EU Over $21 Billion Synthes Deal

Johnson & Johnson has offered unnamed concessions meant to ease the European Commission’s antitrust concerns over the company’s proposed $21.3 billion acquisition of leading orthopedic device maker Synthes. Read More

Boston Scientific Receives Industry’s First FDA Approval for Drug-Eluting Coronary Stent Use in Heart Attack Patients

Boston Scientific’s ION Paclitaxel-Eluting Platinum Chromium Coronary Stent system and TAXUS Liberte Paclitaxel-Eluting Coronary Stent system have received U.S. Food and Drug Administration approval for use in patients experiencing an acute myocardial infarction, or heart attack. Read More

Remote-Controlled Chip Implant Delivers Bone Drug

Medication via remote-control instead of a shot? Scientists implanted microchips in seven women that did just that, oozing out the right dose of a bone-strengthening drug once a day without them even noticing. Read More

Applications Requested for Medical Device Accelerator

Applications are now open for ZeroTo510, a program designed to help entrepreneurs bring medical device products and companies to market, and are being accepted now through April 5. Read More